Helene Lamielle

Clinical & Regulatory Consultant

Helene is a senior clinical and regulatory affairs strategist with 25 years of experience focused in the areas of ophthalmology, cardiovascular, pulmonology and aesthetics. Joining the medical device industry after practicing clinical and surgical ophthalmology in France, Helene held positions of increasing responsibility in R&D, clinical research and regulatory affairs with Laboratoires Domilens SA, transitioning following acquisitions to both Chiron Vision and then Bausch & Lomb. Helene also held a lead role with STAAR Surgical and then Glaukos Corporation, as the Vice President Regulatory, Quality Assurance and Clinical Affairs, focusing on EU clearance, clinical strategy and paving the path for FDA approval of an innovative glaucoma stent. Expanding this experience, Helene joined Rox Medical, Inc., a start-up in the vascular/pulmonology space, concluding initial first-in-human clinical experience and subsequent regulatory approvals and then overseeing clinical development for aesthetic medical devices with Allergan, before expanding her consulting activities in both the US and EU. Helene holds a Medical Degree, trained in ophthalmology and earned an MBA from the University of California, Irvine. Additionally, she is an ISO certified auditor.